Mr. Caccia was featured on a panel that focused on steps medical device manufacturers can take to avoid certain types of compliance failures that have led to enforcement action against some drug companies. The panel was chaired by Sonali P. Gunawardhana, an attorney in Wiley Rein’s Food & Drug Law Practice.

The U.S. Department of Justice (DOJ) has indicated that its enforcement approach for the pharmaceutical industry “is the model for medical devices,” said Mr. Caccia, a former federal prosecutor. He added that the DOJ is increasingly relying on whistleblowers to police the medical device industry.

“The single most important thing you can do, and it is not a catchphrase, is establish a culture of compliance,” he said. “It is really, really, really important that folks feel vested and believe they are working at a company that is committed to doing the right thing.”

SIGNAL Group (formerly McBee Strategic Consulting, LLC) is a wholly owned subsidiary of Wiley Rein. SIGNAL is a total solutions provider—advocacy, strategic communications, research, and digital media—for clients seeking to engage the federal government to achieve competitive advantage, influence public policy, establish new markets, and secure public capital.